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Rongfeng QT001

by Shen Zhen Rong Feng Technology Co., Ltd.

Rongfeng QT001 is a Class II device made by Shen Zhen Rong Feng Technology Co., Ltd., cleared under FDA 510(k) K223044 on 10 May 2023 and listed in FDA GUDID since 17 Oct 2023 (UDI-DI 06973074470045), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K223044

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06973074470045 UDI-DI Date17 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223044 Date10 May 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223044 decided 10 May 2023 Active
  • FDA GUDID UDI-DI 06973074470045 listed 17 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223044
  2. Listed FDA GUDID 06973074470045

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rongfeng
Generic name
Intermittent electronic patient thermometer
Model / reference
QT001
Primary DI / UDI-DI
06973074470045
510(k) Number
FDA product code
FLL
GMDN term
Intermittent electronic patient thermometer
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Intermittent electronic patient thermometer.

Other devices from Shen Zhen Rong Feng Technology Co., Ltd.

  • Rongfeng IR819

    Class II
  • Rongfeng IR903

    Class II
  • Rongfeng QT003

    Class II
  • Rongfeng QT006

    Class II

See all devices from Shen Zhen Rong Feng Technology Co., Ltd. →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)